This is an experimental study to evaluate the efficacy and safety of VT-101 for the treatment of non-muscle invasive bladder cancer
Age 18-75 years old (including 18 and 75 years old), male or female;
Patients with non-muscle-invasive bladder cancer (NMIBC) confirmed by histopathological examination results (pathological stage: high-grade Ta or any T1 level papillary carcinoma or cystoscopic random biopsy confirmed presence of bladder in situ carcinoma (CIS) (with or without papillary carcinoma): according to the results of the biopsy taken within 8 weeks before the first treatment according to the study. If multiple bladder biopsies are needed to confirm eligibility, the last biopsy must be taken within 8 weeks.
T1 HG/G3 tumors without CIS and not eligible for the very high risk group
Tumors present CIS and do not meet the conditions of the very high risk group
A current or past history of muscular invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer;
Urothelial carcinoma of the upper urogenital tract (kidney, renal collecting system, ureter) or prostatic urethra (including urethral CIS) in the 24 months prior to enrollment;
Cystoscopy orimaging examination confirmed the current bladder perforation;
Prior systemic treatment, radiation therapy, or surgery for bladder cancer during screening, in addition to TURBT or bladder biopsy. Intravesical perfusion within 8 weeks prior to initiation of study therapy, with the exception of a single infusion of cytotoxic drugs (e.g. mitomycin C, gemcitabine, pirarubicin, and epirubicin) immediately after TURBT surgery;
Single group
Recombinant oncolytic adenovirus injection solution of VT-101
Biological/VaccineActive ingredient: VT-101 recombinant oncolytic adenovirus Specifications: 2×10\^10 IFU/ml, 0.5ml/ capsule Method of administration: intravesical perfusion
Incidence and severity of possible adverse events after intravesical instillation of VT-101
To evaluate the safety of VT-101 in the treatment of non-muscular invasive bladder cancer.Changes in vital signs, physical examination results, ECOG performance score, laboratory tests, and 12-lead electrocardiogram before, after, and during treatment.
The proportion of patients who suspend or discontinue treatment due to drug toxicity
Dose-Limiting Toxicity (DLT) is defined as an event related to the investigational drug that meets any of the following criteria during the observation period: Any toxicity ≥ Grade 3 except for fatigue lasting ≤3 days or fatigue and weakness that can be relieved through rest or self-adjustment; clinically insignificant reversible laboratory abnormalities ≥ Grade 3. Any toxicity that cannot recover to ≤ Grade 1 baseline level within seven days after discontinuation of dosing.
Complete Response (CR) Rate
To observe the efficacy of VT-101 after intravesical infusion.Complete Response (CR) is defined as either a) negative cystoscopy and negative urine cytology (including atypical) or b) negative cystoscopy, positive urine cytology and negative random bladder biopsy.
Partial Response (PR) Rate
To observe the efficacy of VT-101 after intravesical infusion.Partial Response (PR) is defined as a reduction of the tumor by more than 50% over a period of not less than 4 weeks, which can be measured by either double-path or single-path measurements. (a) Double diameter measure1) Single lesion: tumor area (the product of the two largest vertical diameters of the mass) reduced by ≥50%; 2) Multiple lesions: the sum of the product of the two largest vertical diameters of multiple masses is reduced by more than 50%. (b) Single diameter measurement: The measured value of linear mass is reduced by more than 50%.
Stable Disease (SD)
To observe the efficacy of VT-101 after intravesical infusion.Stable disease (SD) is defined as being somewhere between partial remission and disease progression.
Progressive Disease (PD)
To observe the efficacy of VT-101 after intravesical infusion.Progressive Disease (PD) is defined as a 20% increase in the sum of the longest tumor diameters or the appearance of one or more new lesions compared to the sum of the smallest tumor longest diameters recorded after the start of treatment.
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The Affiliated Hospital of Xuzhou Medical University
Lead sponsor
Xuzhou Medical University
Collaborator
